Fexofenadine Hydrochloride Tablet
NDC Package 84324-045-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fexofenadine Hydrochloride tablets is  Adults and children 12 years of age and over Take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours Children under 12 years of age Do not use Adults 65 years of age and older Ask a doctorConsumers with kidney disease Ask a doctor. This formulation utilizes a tablet delivery system. Marketed by Nuvicare Llc, this product is identified by NDC 84324-045 and is authorized under FDA application ANDA204507.

Identification & Billing

NDC Package Code
84324-045-01
Package Description
60 TABLET in 1 BOTTLE
Product Code
84324-045
11-Digit Billing Format
84324004501

Clinical Specifications

Proprietary Name
Fexofenadine Hydrochloride
Non-Proprietary Name
Fexofenadine Hydrochloride
Substance Name
Fexofenadine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FEXOFENADINE HYDROCHLORIDE 60 mg/1
Pharmacologic Class
Usage Information
 Adults and children 12 years of age and over Take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours Children under 12 years of age Do not use Adults 65 years of age and older Ask a doctorConsumers with kidney disease Ask a doctor

Regulatory & Marketing

Labeler Name
Nuvicare Llc
Product Type
Human Otc Drug
FDA Application #
ANDA204507
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-30-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 84324-045-01 identifies a specific commercial package of 60 tablet in 1 bottle of Fexofenadine Hydrochloride, a human over the counter drug labeled by Nuvicare Llc. This tablet is formulated for oral use and contains fexofenadine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Nuvicare Llc on July 30, 2026. The current certification is valid through December 31, 2027.

How is this Nuvicare Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84324004501. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
84324-045-01
11-Digit CMS (5-4-2)
84324-0045-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.